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Publication numberUS5114580 A
Publication typeGrant
Application numberUS 07/540,747
Publication dateMay 19, 1992
Filing dateJun 20, 1990
Priority dateJun 20, 1989
Fee statusPaid
Publication number07540747, 540747, US 5114580 A, US 5114580A, US-A-5114580, US5114580 A, US5114580A
InventorsSuhail Ahmad, James J. Cole, William Jensen
Original AssigneeThe Board Of Regents Of The University Of Washington
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Combined hemofiltration and hemodialysis system
US 5114580 A
Abstract
A hemodialysis system has a blood circuit and a hemofiltrate circuit interconnected at a hemofilter and an air collection chamber. If an infusion of sterile fluid to the returning blood is needed during the dialysis treatment, filtrate in the filtrate circuit is pumped back into the blood circuit. This is also done to purge the blood circuit of blood and return it to the patient at the conclusiion of a dialysis treatment. A blood pump in the blood circuit incorporates a flexible vessel in conjunction with pinch valves which self expand in a controlled manner from a compressed condition to fill with blood from the patient in a suction stroke controlled by the patient's blood delivery rate. Compression of the vessel by an external member then forces the blood through the rest of the blood circuit.
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Claims(28)
We claim:
1. A hemodialysis system comprising:
a blood pump having a blood outlet and a blood inlet for connection to a patient via an arterial route;
a hemofilter having a blood inlet connected to said blood outlet of the pump, and having a blood outlet and a filtrate outlet;
a hemodialyzer having a blood outlet, a blood inlet connected to said blood outlet of the hemofilter, and a dialysate inlet and outlet;
a filtrate reservoir;
an air-removal and filtrate pump having an outlet connected to said reservoir and having an inlet;
an air collection chamber having a blood inlet connected to said blood outlet of the hemodialyzer, a blood outlet for connection to a patient via a venous route, and an air removal outlet;
tube and valve means selectively connecting and disconnecting said inlet of the air-removal and filtrate pump with said filtrate outlet of the hemofilter and air removal outlets; and means for introducing an anti-coagulant to said air collection chamber.
2. A hemodialysis system according to claim 1 in which additional tube and valve means selectively connect said blood outlet of said blood pump with said reservoir.
3. A blood pumping system for a hemodialysis circuit comprising:
a flexible vessel connected to flexible ingress and egress tubes for entry and discharge of blood from a patient, said vessel and tubes being adapted to self return to their original shapes when released after being collapsed;
ingress and egress pinch valve mechanisms arranged for selectively collapsing said ingress and egress tubes, respectively;
compression means for selectively collapsing said vessel during a compression stroke to discharge blood into said egress tube when said egress tube is open and said ingress tube is collapsed, said compression means also having a return stroke permitting said vessel to return to its original shape to create a suction in said ingress tube when said egress tube is collapsed and said ingress tube is open; and
control means operatively connected to said valve mechanisms and compression means for operating in a cycle wherein said ingress tube is open and said egress tube is closed during said return stroke, wherein said ingress tube is closed and said egress tube is open during said compression stroke, and wherein, said ingress tube is closed before said egress tube is opened at the start of said compression stroke.
4. A hemodialysis method comprising:
circulating a patient's blood from and back to the patient in a closed primary blood circuit through a hemofilter, hemodialyzer, and air extraction chamber arranged in series;
collecting filtrate from the hemofilter in a reservoir located in a closed secondary circuit connected to said primary circuit; and
pumping air from said air extraction chamber to said reservoir through said secondary circuit to remove all air from the circulating blood before return to the patient.
5. A hemodialysis method according to claim 4 in which collected filtrate is returned to said circuit.
6. A hemodialysis method according to claim 4 in which collected filtrate is returned to the circuit via the air collection chamber.
7. A hemodialysis method according to claim 4 in which an anti-coagulant is introduced to said air collection chamber to prevent blood coagulation in said circuit.
8. A hemodialysis method comprising:
introducing blood from a patient into an external blood circuit connected to the patient;
isolating equal volumetric increments of the introduced blood in a flexible vessel in said external circuit;
linearly compressing said vessel each time only that it contains one of said increments, and advancing the respective increment along said external circuit while the vessel is being compressed;
filtering the advancing increments and thereby removing excess fluid as filtrate; and
diffusing solutes from each increment as its advances further along said external circuit for return to the patient.
9. A hemodialysis method according to claim 8 in which said filtering of the advancing increments of blood comprises removing and storing excess fluid from the blood, and returning some of said stored excess fluid to said external circuit from time to time to control the fluid content of the blood.
10. A method according to claim 8 in which said filtrate is collected in a filtrate circuit, and in which some of said filtrate is returned from said filtrate circuit to said external circuit when dialysis has been completed to displace the blood remaining in said external circuit and thereby return such blood to the patient.
11. A hemodialysis method comprising:
circulating blood during a treatment period from a patient through an external circuit and back to the patient;
filtering excess fluid from the circulating blood and collecting the excess fluid filtrate;
diffusing urea from the circulating blood; and
displacing the blood remaining in said external circuit at the close of said treatment period with the collected filtrate to return such blood to the patient.
12. A hemodialysis method comprising:
circulating blood during a treatment period from a patient through an external circuit and back to the patient;
filtering excess fluid from the circulating blood by a hemofilter in said external circuit and collecting the excess fluid filtrate in a filtrate reservoir within a filtrate circuit in a sterile environment;
dialyzing the circulating blood at a dialyzer in said external circuit; and
displacing the blood remaining in said external blood circuit at the close of said treatment period with the collected excess fluid filtrate to return such remaining blood to the patient.
13. A method according to claim 12 including the following additional steps:
disconnecting the external circuit from the patient and closing the external circuit;
introducing a cleaning agent on the dialysate side of said dialyzer; and
passing said cleaning agent through the dialyzer membrane into said external circuit.
14. A method according to claim 13 including the following additional steps:
removing said cleaning agent and introducing a sterilant to said external circuit; and
removing said sterilant in preparation for a dialysis treatment by dialysis of the sterilant through said dialyzer membrane.
15. A hemodialysis system comprising:
a hemodialyzer;
a flexible vessel adapted to self-expand to its original shape after being deformed by compression;
a closed blood circuit for passing blood from a patient to said vessel and from said vessel to the hemodialyzer, and for returning blood from the hemodialyzer to the patient, said blood circuit having an ingress valve between said vessel and the patient, and an egress valve between said vessel and the hemodialyzer;
apparatus for alternately compressing and releasing said vessel in alternating compression and release strokes; and
control means for starting each compression stroke after a predetermined operation of said vessel responsive to flow of blood from the patient in accordance with the patient's own blood delivery rate, and for controlling the start of each release stroke, said control means being operatively associated with said valves for opening said ingress valve and closing said egress valve preliminary to the start of each release stroke, and for closing the ingress valve and opening the egress valve preliminary to the start of each compression stroke.
16. A system according to claim 15 in which said control means includes a sensor normally contacting said vessel and adapted to deactivate said apparatus during said release stroke whenever the release stroke progresses beyond the expansion of the vessel.
17. A hemodialysis system comprising;
a hemodialyzer;
a blood flow circuit for connection to a patient including a flexible vessel and flexible input and output tubes leading to said vessel from the patient and leading from the vessel to said hemodialyzer, said vessel and tubes having a self return characteristic when collapsed; and
squeeze means external to said tubes and external to said vessel for selectively collapsing them in a pumping cycle wherein said vessel collapses in a pumping stroke and expands in a suction stroke, wherein a portion of said input tube is collapsed as an input valve prior to the start of said pumping stroke and is released for expansion at the beginning of said suction stroke, and wherein a portion of said output tube is collapsed as an output valve at the beginning of said suction stroke and is released for expansion at the beginning of said pumping stroke; and
control means for activating said squeeze means to start said pumping stroke only when said vessel contains a preset volume of blood.
18. A blood pumping system comprising:
a blood pumping system for a hemodialysis circuit comprising:
a flexible vessel connected to flexible ingress and egress tubes for entry and discharge of blood from a patient, said vessel and tubes being adapted to self return to their original shapes when released after being collapsed;
ingress and egress pinch valve mechanisms arranged for selectively collapsing said ingress and egress tubes, respectively;
compression means including a rotary combination crank and cam member, a compression shoe engaging said vessel, and a link pivotally connected to said member and shoe for linearly reciprocating said shoe responsive to turning of said crank and cam member to alternately move said shoe in a vessel compressing stroke and a vessel expansion stroke; and
pinch valve mechanisms including rockers with pinch elements at one end of the rockers and cam followers at the other end thereof engaging said crank and cam member while it turns to responsively pinch and release portions of said tubes by said pinch elements in a cycle wherein said ingress tube is open and said egress tube is closed during said expansion stroke and wherein said ingress tube is closed and said egress tube is open during said compression stroke.
19. A hemodialysis system comprising:
a hemofilter having a membrane with a blood side and a filtrate side;
a hemodialyzer having a membrane with a blood side and a dialysate side;
an air removal station;
a reservoir connected by a filtrate circuit to said filtrate side of the hemofilter and to the top of said station;
pump means for circulating blood in a blood circuit from a patient to said blood sides and back to the patient via said station; and
circulating means for circulating air through said filtrate circuit to said reservoir from the circulating blood in said blood circuit at said station, and for circulating filtrate to said reservoir through said filtrate circuit.
20. A hemodialysis system according to claim 19 in which anti-coagulant introducing means is connected to said station.
21. A hemodialysis system according to claim 19 in which said circulating means comprises a reversible pump, a pinch valve between said pump and said hemofilter, and a pinch valve between said pump and said station, whereby filtrate can be pumped from said hemofilter to said reservoir, or filtrate can be pumped from said reservoir to said blood circuit at said station or to said blood circuit at said hemofilter via the membrane of the hemofilter.
22. A hemodialysis system according to claim 21 in which said circulating means includes a reversible pump, and said filtrate circuit also connects with said blood circuit at the outlet side of said pump means by a branch having a pinch valve and a pressure sensor located between said pinch valve and said pump means.
23. A hemodialysis system comprising:
a blood pump having a blood outlet and a blood inlet for connection to a patient via an arterial route;
a hemofilter having a blood inlet connected to said blood outlet of the pump, and having a blood outlet and a filtrate outlet;
a hemodialyzer having a blood outlet, a blood inlet connected to said blood outlet of the hemofilter, and a dialysate inlet and outlet;
a filtrate reservoir;
an air-removal and filtrate pump having an outlet connected to said reservoir and having an inlet;
an air extraction chamber having a blood inlet connected to said blood outlet of the hemodialyzer, a blood outlet for connection to a patient via a venous route, and an air removal outlet;
tube and valve means selectively connecting and disconnecting said inlet of the air-removal and filtrate pump with said filtrate outlet of the hemofilter and air removal outlets; and
means for introducing an anti-coagulant to said air extraction chamber;
said pumps being selectively reversible to pump filtrate from said reservoir to the hemofilter and/or air extraction chamber to enable return of the blood in the system to the patient via the arterial and venous routes at the close of a hemodialysis treatment.
24. A hemodialysis method comprising:
circulating a patient's blood from and back tot he patient in a circuit through a hemofilter, hemodialyzer, and air extraction chamber arranged in series;
collecting filtrate from the hemofilter in a reservoir;
extracting air from said air extracting chamber and collecting it in said reservoir to remove air from the circulating blood before return to the patient;
and returning some of the collected filtrate from the reservoir to the circuit at the close of dialysis such as to return the patient's blood in the circuit to the patient.
25. A hemodialysis method comprising:
introducing blood from a patient into an external blood circuit connected to the patient;
isolating volumetric increments of the introduced blood in a flexible vessel in said external circuit;
linearly compressing said vessel each time only that it contains one of said increments, and advancing the respective increment along said external circuit while the vessel is being compressed;
filtering the advancing increments and thereby removing excess fluid as filtrate;
collecting said filtrate in a filtrate circuit;
diffusing solutes from each increment as its advances further along said external circuit for return to the patient; and
returning some of said filtrate from said filtrate circuit to said external circuit when dialysis has been completed to displace the blood remaining in said external circuit and thereby return such blood to the patient.
26. A hemodialysis system comprising:
a blood circuit;
a filtrate circuit connected to said blood circuit;
means for introducing blood from a patient into said blood circuit and for returning blood from said blood circuit to the patient;
means for isolating equal volumetric increments of the introduced blood in a flexible vessel in said blood circuit;
means for compressing said vessel each time, and only each time, that it contains one of said increments so that the respective increment is advanced along said blood circuit;
filtering means for filtering the advancing increments to remove excess fluid as filtrate;
means for collecting said filtrate in said filtrate circuit;
means for selectively returning some of said filtrate from said filtrate circuit to said blood circuit for selectively controlling the amount of fluid in the blood returned to the patient.
27. A hemodialysis system according to claim 26 in which means are provided for diffusing solutes from each said increment as it advances along said blood circuit from said filtering means for return to the patient.
28. A hemodialysis system comprising:
a blood circuit;
a filtrate circuit connected to said blood circuit;
means for introducing blood from a patient into said blood circuit;
means for isolating equal volumetric increments of the introduced blood in a flexible vessel in said blood circuit;
means for linearly compressing said vessel each time, and only each time, that it contains one of said increments, and advancing the respective increment along said blood circuit while the vessel is being compressed;
means for filtering the advancing increments to remove excess fluid as filtrate;
means for collecting said filtrate in said filtrate circuit;
means for diffusing solutes from each increment as it advances further along said blood circuit for return to the patient; and
means for selectively returning some of said filtrate from said filtrate circuit to said blood circuit.
Description
CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of our co-pending application Ser. No. 368,665, filed Jun. 20, 1989, entitled "Automated Hemodialysis System,"now abandoned.

TECHNICAL FIELD

The present invention relates to hemodialysis systems, and more particularly, to an improved such system having blood and hemofiltrate circuits interconnected at a hemofilter and an air collection chamber, and having a novel blood pump operating according to the patient's blood delivery rate.

BACKGROUND OF THE INVENTION

Hemodialysis treatment is employed as a therapeutic measure when a patient's kidneys no longer perform their blood purifying function because of disease or traumatic removal. Kidney failure results in the accumulation of toxic waste in the patient's blood and eventual death from uremic poisoning, unless the waste material is removed by some artificial means. In hemodialysis of the type to which the present invention relates, the patient's blood is circulated from the patient in a closed blood circuit by a pump to one side of a membrane contained within a hemodialyzer (i.e., artificial kidney). The membrane has pores of microscopic size through which waste products from the blood pass. The pores are, however, too small to permit blood cells and proteins to leave the body. A dialysis fluid (dialysate) is circulated on the other side of the hemodialyzer membrane to remove the waste products. The dialyzed blood is returned to the patient.

The blood pump normally used in contemporary dialysis systems is a roller pump in which rollers on rotating arms radiating from a motor-driven shaft progressively squeeze closed a section of flexible tubing in the circuit connecting the patient's blood system to the hemodialyzer. The speed of the pump motor is set to give a pump output in accordance with the anticipated patient's blood delivery rate. However, this delivery rate will normally vary during treatment and may drop below the pump output setting, a condition likely to collapse and obstruct the connection tubing. In contemporary dialysis machines an alarm is triggered and the blood pump is stopped if the patient's blood delivery rate drops below the pump flow rate setting. To minimize the occurrence of such a condition the blood pump is normally given a flow rate setting below the anticipated blood flow rate from the patient to allow for downward fluctuations of the patient's blood delivery rate. Hence, the treatment time is longer than would be necessary if the pumping rate continuously matched the patient's blood delivery rate.

SUMMARY OF THE INVENTION

The present invention regulates the blood flow rate through the blood circuit of the dialysis system according to the available blood delivery rate from the patient, thereby avoiding recurring alarms and reducing staffing needs. In some instances, optimization of blood flow may also shorten dialysis treatment time. Regulation by the blood delivery rate of the patient is accomplished in the practice of the present invention by providing a blood pump having a compressible pump chamber and having flexible ingress and egress tubes at opposite ends of the chamber which extend through pinching devices functioning together with the tubes as ingress and egress pinch valves. The pump chamber walls are sufficiently elastic to self return the pump chamber to its normal size from a compressed condition when compression is released.

Expansion of the pump chamber toward its normal size from a compressed empty condition creates a suction which aids in filling the chamber with blood from the patient. When filling of the pump chamber is complete the ingress valve closes and the egress valve opens. Then compression of the pump chamber commences for delivery of blood from the chamber to the rest of the dialysis system during a compression stroke. At the close of the chamber compression stroke the compression device commences a chamber expansion stroke with the egress valve closed and the ingress valve open. During this chamber expansion stroke the compressing device remains in engagement with a wall of the pump chamber, and the chamber expansion stroke is permitted to advance only at a pace determined by the blood delivery rate from the patient as it then exists.

In contemporary dialysis systems usually the tubing is replaced after each treatment. This is always done in dialysis treatment centers in which multiple patients use the same dialysis machine. The time and expense involved in tubing replacement is significant. The present invention makes it possible to backwash the tubing and other components of the dialysis system so as to make it possible to reuse the system with the tubing remaining in place on the machine for several treatments in situations such as home dialysis in which the dialysis machine is only used by one patient. The present invention also makes it possible in installations in which a dialysis machine is used for treating multiple patients in sequence to remove the tubing and system elements to which the tubing is connected as a module for reuse for the same patient.

Occasionally a patient will experience discomfort or shock symptoms. In the past such occurrences have been remedied by an infusion of a sterile solution from an external source to the returning blood. The present invention provides a filtrate circuit integrated in a closed system with the blood circuit in the dialysis machine in such a manner that some of the filtrate can readily be pumped back into the blood circuit and returned to the patient rather than supplementing with fluids from an external source.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic of a hemofiltration and hemodialysis system embodying the present invention.

FIG. 2 is a schematic of a valve block for use during post-treatment operations on the system.

FIG. 3 is a layout of the pumping portion of the system when a single pumping chamber is used, and showing the condition when the chamber is slightly compressed.

FIG. 4 is a layout showing use of a two-chamber pumping arrangement in the system, and illustrating the condition when one chamber is nearly fully compressed and the other chamber is nearly fully expanded.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the present invention a blood circuit which includes a supply-regulated reversible pump 18 with ingress and egress pinch valves 19-20, the blood side of a hemofilter 22, a hemodialyzer 24, and an air-collection chamber 26 arranged in series, interacts in a closed system with a filtrate circuit comprising the filtrate side of the hemofilter 22, a reversible roller pump 28, a reservoir 30, and pinch valves 32, 33. A suitable anticoagulant such as heparin is introduced and metered to the blood circuit by a syringe pump 34 via a tube 35 which preferably discharges to the air-collection chamber 26.

When a patient is expected to be on dialysis for an extended period of time it is common to surgically create for ease of blood access an enlarged vein in one of the patient's limbs. In preparation for a dialysis treatment, two needles are inserted a few centimeters apart into the blood access. The upstream needle is connected to a flexible tube 36 (hereinafter called the "arterial tube") leading to the pump 18, and the downstream needle is connected to a flexible tube 37 (hereinafter called the "venous tube") returning to the patient from the air-collection chamber 26. In some instances a single needle is used, in which case the arterial and venous tubes 36, 37 are both connected to the needle via a T-fitting.

The tubes 36, 37 are part of the blood circuit together with a flexible tube 38 between the pump 18 and hemofilter 22, tube 39 between the hemofilter 22 and dialyzer 24, and tube 40 connecting the dialyzer to the air-collection chamber 26. The tubing in the filtrate system comprises a flexible tube 41 connected to the filtrate side of the hemofilter 22, a flexible tube 42 connected to the top of the air-collection chamber 26, and a flexible tube 43 leading from the bottom of the reservoir 30 to a Y-connection with the tubes 41, 42. The reservoir 30 may comprise a vessel with a filtered air vent or a collapsible air-tight bag. It is also preferred to provide a tube 44 extending from the pump end of the tube 38 to a connection with the tube 43 and to equip the tube 44 with a pinch valve 46. The tubes 41, 42, and 44 preferably have branches containing pressure sensors 45-47, respectively, for pressure monitoring. The 30 dialysate side of the dialyzer 24 has supply and discharge ports 48, 49 connected to a dialysate supply and to a drain.

Directing attention to FIG. 3, the blood pump 18 has an elongated squeeze chamber 50 functioning between pinch valves 19-20 acting on the arterial tube 36 and on the egress tube 38 leading to the hemofilter 22. The squeeze chamber 50 is located between a stationary wall 51 and a reciprocating compression shoe 52. The shoe 52 is mounted on a slide rod 53 which is slowly driven back and forth by a driven shaft 54 via a combination crank and cam member 55 and a connecting link 56 which is pivotally connected at its ends by pins 57 to member 55 and slide rod 53. A reversible motor with a gear reduction unit (not shown) may be used to drive the shaft 54.

The member 55 has a lifting lobe 55a which encompasses about 190 degrees and a return section 55b. Riding on the periphery of member 55 are two diametrically opposite cam followers 58, 59 mounted on the ends of rockers 60, 61. These are centrally pivotally mounted at 60a, 61a and are spring loaded to swing the cam followers into constant engagement with member 55. On their ends opposite from the cam followers 58, 59 the rockers 60, 61 carry round pinch elements 62, 63 which oppose stationary blocks 64, 65. The pinch element 63 and block 65 comprise the ingress valve 19, and the pinch element 63 and block 64 comprise the egress valve 20. The arterial ingress tube 36 passes between the pinch element 63 and the block 65, and the egress tube 38 passes between the pinch element 62 and the block 64. When the cam followers 58, 59 are lifted radially away from the shaft 54 by the lobe 55a as the shaft 54 turns clockwise, for example, the pinch elements 62, 63 are urged toward the blocks 64, 65 and cooperate therewith to respectively pinch the tubes 38, 36 to a closed position. When the cam followers 58, 59 return to engagement with the return section 55b, the pinch elements 62, 63 are moved out of tube pinching position, thereby opening tubes 38 and 36, respectively.

The stationary wall 51 is interrupted to expose a projecting button 68 extending from a swing arm 69 which is arranged to engage a microswitch 70 when the swing arm 69 is swung away from the compression chamber 50 responsive to engagement of the button 68 by the opposing wall of the chamber 50. The button 68 is preferably connected to the swing arm 69 by an adjusting screw 71 so that the extent of engagement of the chamber wall necessary to operate the microswitch 70 can be readily adjusted. A spring 72 biases the swing arm 69 toward the chamber 50. The microswitch 70 is wired in series with the motor driving the shaft 54 so that the motor operates only when the microswitch is closed.

As will later be discussed, normally at the start of a dialysis treatment with the present invention, the system will be filled with sterile dialysate which is not harmful to the patient if introduced to the patient. As previously indicated, the patient is commonly connected to the arterial and venous tubes 36, 37 via needles inserted through the wall of a blood access vein. Dialysis is normally commenced with the ingress valve 19 of the blood pump open and the egress valve 20 thereof closed. As the vessel 50 expands due to its own elasticity, it creates sufficient suction acting in conjunction with the pressure of the blood exiting the patient, to potentially fill the vessel 50.

When blood initially enters the squeeze chamber 50 from the patient, normally the microswitch 70 is open and the motor driven shaft 54 is stationary. Then as the chamber 50 expands and begins to fill with blood; it firmly engages the compression shoe 52, wall 51, and button 68. The microswitch 70 is responsively closed, thereby starting the motor to drive shaft 54 so that expansion of the chamber 50 can continue as entry flow of the blood from the patient continues. If the shaft 54 turns so rapidly that the slide rod 53 moves away from the stationary wall 51 at a rate faster than the expansion rate of the squeeze chamber 50, the microswitch 70 will open, thereby stopping the motor until the expansion of the chamber 50 catches up to the then position of the compression shoe 52. Thus the blood pump 18 is regulated by the supply of blood from the patient. Filling of the chamber 50 continues until the cam follower 59 begins to climb down from the lobe 55a to close the ingress valve 19 and, the cam follower 58 reaches the lobe 55a to open the egress valve 20 after the ingress valve is closed. By this time, the connecting link 56 has begun to reverse its stroke to commence compression of the chamber 50 and the start of a pumping cycle. Compression continues until the start of another chamber filling cycle.

When the egress valve 20 opens at the start of a pumping cycle, and blood is forced from the vessel 50 by the compressing action of the shoe 52, the pinch valve 32 in the filtrate circuit is opened and the filtrate pump 28 is started so that when the pumped blood passes through the hemofilter 22, filtrate from the blood will be pumped from the hemofilter to the reservoir 30 via tubes 41 and 43. The circulating blood then passes through tube 39 to the dialyzer 24 for treatment by a suitable dialysate passing on the outside of the multitude of tubular membranes within which the blood is passing. The blood flows from the dialyzer into the air collection chamber 26 where it is treated with an anticoagulant fed by syringe pump 34. This pump may have its plunger connected to a slide-mounted rack operated by a pinion rotated by a stepper motor. Treated blood returns to the patient from the chamber 26 through the venous tube 37.

While the blood initially passes through the blood circuit at the start of the treatment, it displaces the dialysate in the blood circuit, and the displaced dialysate passes through the venous tube 37 into the patient. When the reservoir 30 is filled a predetermined amount corresponding to the increased liquid retention of the patient since the last dialysis treatment, the filtrate pump 28 is stopped and the pinch valve 32 is closed. If the patient shows signs of discomfort or distress because of a liquid shortage caused by the treatment, the filtrate pump 28 is started in reverse with the pinch valve 33 open so that filtrate can be reintroduced to the patient via the tube 42, air collection chamber 26, and venous tube 37 where it blends with the returning blood to the patient.

After a dialysis treatment is completed it is necessary to clean all of the system components to be reused. Then the system is sterilized with a suitable sterilant solution which is left in the system until the system is to be again activated for another treatment. At that time the sterilant is replaced by dialysate before the system is connected to the patient.

One of the advantages of the system is that the vessel 50 and related ingress and egress blood tubes 36, 38 can be removed laterally as a unit from the blood pump and pinch valve mechanisms in the blood circuit, and that the filtering tube 43 can be removed laterally from the roller pump 28 in the filtrate circuit without being disconnected. Specifically, vessel 50 can be removed from between the compression shoe 52 and wall 51; tubes 36 and 38 can be removed from between pinch elements 62, 63 and blocks 64, 65; the tubes 41, 42 and 44 can be removed from the pinch valves 45, 46 and 47; and the filtrate tube 43 can be removed from between the roller elements 28a and arcuate abutment plate 28b of the roller pump 28. Thus, all of the system subjected to contact with a patient's blood or filtrate during dialysis, including all tubes, valves, pressure monitors, the reservoir 30, hemofilter 22, dialyzer 24, air collection unit 26, and anticoagulant pump 34, can be removed as a module from the dialysis machine for storage to be used for subsequent dialysis treatments of the same patient. Furthermore, this module can be cleaned, tested, and sterilized on a processing machine, thereby freeing the dialysis machine for use on another patient after inserting of that patient's module. This processing machine preferably includes reversible pumps and pinch valve mechanisms arranged to function on the vessel 50, blood tubes 36, 38 and filtrate tubes 41, 42, and 43 by a squeezing action in a suitable manner like the blood pump 18 and its related pinch valves 19-20, and filtrate pump 28 and pinch valves 32, 33 and 46.

Since post-treatment operations on the system will be basically the same whether or not performed on another machine, the following example will be with reference to the machine previously described.

After dialysis is complete and the blood in the blood circuit has been returned to the patient and tubes 36, 37 have been disconnected from the patient, it is preferred to connect them to a valve block 74 (FIG. 2) having four ports, one for the arterial tube 36, a second for the venous tube 37, a third for a drain tube 75, and a fourth for an infeed tube 76. The block 58 contains a cross-over valve 78 for connecting the tubes 36, 37 and respective valves 79, 80 for controlling flow through the drain and infeed tubes 75, 76.

To clean blood residue from the system it is necessary to flush and back-wash the components several times with a suitable flushing solution which will pass through the pores in the multitude of tubular membranes in the filter 22 and dialyzer 24. The flushing solution is preferably introduced to the system through the dialysate infeed port 48 of the dialyzer 24 and the infeed tube 76 to the block 74.

The system can initially be drained by opening the drain valve 79 and cross-over valve 78, and reversing the filtrate pump 28 and blood pump 18 for down-flow with the pinch valves 32, 33 and 46 open. Then the system can be filled with a suitable cleaning solution such as a weak household bleach through the infeed tube 76 with valve 79 closed and the filtrate pump 28 and blood pump 20 reversed for up-flow. The hemodialyzer 24 can be back-washed by introducing cleaning solution through the dialysate intake 48. Repeatedly draining and filling of the system with the cleaning solution and then with filtered water cleans out all blood and blood filtrate residue from the system components. Then the system is filled with a suitable sterilant such as formaldehyde.

When the system is to be used again, the sterilant is removed from the system, preferably by dialysis. Dialysate is circulated through the dialyzer 24 with the arterial and venous tubes 36, 37 connected together via valve 78 with valves 79, 80 being closed, and the blood pump 18 operating in up-flow mode. The filtrate pump 28 is operated in the up-flow direction with the pinch valves 32, 33 and 46 open to fill the reservoir 30, and then is reversed. This sequence is repeated until all of the sterilant has been purged from the system through the dialyzer membrane and dialysate discharge port 49. During the procedure the anticoagulant pump 34 is operated a sufficient time to remove sterilant from the connecting tube between the pump 34 and the air collection chamber 26. When the sterilant has been removed by dialysis in preparation for patient treatment, the system contains sterile dialysate.

It is preferred to test the integrity and permeability of the hemofilter and hemodialyzer membranes between dialysis treatments, normally before the sterilant is added. For membrane leakage testing, the reservoir 30 is emptied and the blood pump 18 is run forward at approximately 200 ml/min. Simultaneously, the filtrate pump 28 is run in reverse to draw air through the empty filtrate reservoir 30 and pump it through tube 41, with valve 32 open, into the jacket of hemofilter 22 until the pressure reaches a prescribed limit (e.g., 250 mmHg). Both pumps 18, 28 are then stopped and pressure decay is monitored for approximately 4 minutes. Next, air from the reservoir 30 is pumped through valve 33 into the blood circuit via tube 42 and air collection chamber 26 until pressured to a similar level monitored by sensor 46. If pressure decay read at sensor 45 or 40 exceeds limits appropriate to the hemofilter and hemodialyzer being used, the system will be in a failure condition. This membrane leakage test is based on the fact that air will pass through a small defect more rapidly than a liquid, and therefore is a more sensitive indicator of membrane integrity.

The present invention measures membrane permeability in the hemodialyzer 24 by filling the blood lines with filtrate to a preselected pressure, and then monitoring the pumping rate required to maintain that pressure. This is accomplished by activating the filtrate pump 28 in reverse, thereby causing filtrate to pass from the filtrate reservoir 30 through valve 33 and tube 42 into the blood circuit via the air collection chamber 26. Filling continues until a predetermined pressure (for example, 250 mmHg) is reached. During the fill, some fluid will have passed across the hemofilter membrane, equalizing the pressure between the hemofilter 22 and the tube 41 to valve 32. At this point, fluid can only leave the blood circuit by passing across the hemodialyzer membrane to the dialysate side; the faster the rate, the greater the permeability. After pressurization, the pumping rate of the filtrate pump 28 required to maintain this pressure is monitored. If this rate is below the desired threshold value for the particular hemodialyzer model, membrane permeability is inadequate.

A similar test may be applied to the hemofilter 22 by opening valve 32 and pressurizing the hemofilter jacket, with filtration occurring from the jacket to the blood side of the hemofilter. A pumping rate below the ordinary threshold indicates excessive membrane blockage. It should be noted that the hemofilter and hemodialyzer tests also may be performed by pressurizing the system as described herein, then stopping the filtrate pump 28 and monitoring the rate of pressure decay as the indication of membrane permeability of the hemodialyzer 24 and the hemofilter 22.

The invention has been described with respect to a single blood pump 18. However, as shown in FIG. 4, the blood pump mechanisms is ideal for operating two blood pumps 18, 18' in alternating cycles. In the two-pump arrangement the slide rod 53 is connected to a second compression shoe 52' operating with a second squeeze chamber 50'. This second chamber connects at its ends with ingress and egress tube branches 36', 38' which pass between the pinch elements 62, 63 and a second set of stationary blocks 64', 65'. A second microswitch 70' is operated in response to expansion of the chamber 50' against a wall 51' and second button 68' by way of an adjustment screw 71' and swing arm 69' which is biased by a spring 72'.

By the described two-pump system while one of the chambers 50, 50' is being compressed to discharge blood, the other chamber is being filled from the patient. Feedback from one squeeze chamber to the other is prevented by the fact that the squeeze elements 62, 63 alternatively pinch the ingress and egress tubes for the chambers. The electrical circuit from the blood pump motor to the switches 70, 70' is such that the motor can only be activated by alternate filling of the squeeze chambers 50, 50'.

The pressure sensor 47 makes it possible to monitor the output pressure of the blood pump(s), and the pressure sensors 45, 46 enable pressure monitoring of the filtrate circuit. It will be appreciated that the described system can be controlled by an automated electrical control system connected to the motor for the blood pump(s) and filtrate pump 28, and to solenoids operating the pinch elements of the valves 32, 33 and 46. It will also be appreciated that the ingress and egress pinch valves 19, 20 can have their pinch elements 62, 63 solenoid operated, and that other mechanisms can be used to operate the compression shoes 52, 52'.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3579441 *Apr 19, 1968May 18, 1971HydronauticsBlood purification by dual filtration
US3902490 *Mar 27, 1974Sep 2, 1975Univ UtahPortable artificial kidney system
US4500309 *May 7, 1982Feb 19, 1985The Kansas University Endowment AssociationHydrated trisodium citrate; infusing calcium compound into blood returned to patient
US4514295 *Aug 2, 1982Apr 30, 1985Fresenius AgDialysis apparatus
US4596550 *Jan 27, 1984Jun 24, 1986Baxter Travenol Laboratories, Inc.Method and apparatus for ultrafiltration measurement in a two pump dialysis system
US4601712 *Nov 16, 1983Jul 22, 1986Gould Inc.Drip chamber
US4650458 *Jun 7, 1985Mar 17, 1987Gambro Lundia AbApparatus for the measurement of fluid flow
US4676905 *Dec 14, 1976Jun 30, 1987Toray Industries, Inc.Fluid separation method and apparatus
US4702829 *Dec 6, 1985Oct 27, 1987Fresenius AgClosed dialysis solution cycle
US4857199 *Oct 20, 1987Aug 15, 1989Hospal IndustrieMethod and system for pumping two liquids in equal quantities in an artificial kidney
US4885001 *Jun 3, 1988Dec 5, 1989Cobe Laboratories, Inc.Pump with plural flow lines
US4897189 *Jan 15, 1988Jan 30, 1990Research Corporation LimitedBlood purification apparatus
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US5591344 *Feb 13, 1995Jan 7, 1997Aksys, Ltd.Hot water disinfection of dialysis machines, including the extracorporeal circuit thereof
US5630935 *Nov 17, 1995May 20, 1997Aksys, Ltd.Pressure relief valve with sample removal port
US5645734 *Feb 23, 1995Jul 8, 1997Aksys, Ltd.Dialysate separation method
US5658456 *Nov 17, 1995Aug 19, 1997Aksys, Ltd.Electronic reader; ?touch? memory buttons, bar codes, magnetic strips
US5670050 *Nov 17, 1995Sep 23, 1997Aksys, Ltd.Method for detection of leakage of blood
US5674390 *Mar 1, 1996Oct 7, 1997Aksys, Ltd.Dialysis machine with leakage detection
US5674397 *Feb 5, 1996Oct 7, 1997Aksys, Ltd.Debubblers
US5674404 *Apr 30, 1996Oct 7, 1997Aksys, Ltd.Filter integrity test method for dialysis machines
US5690821 *Nov 17, 1995Nov 25, 1997Aksys, Ltd.Apparatus for supplying a batch of chemicals to a dialysate tank
US5690831 *Nov 17, 1995Nov 25, 1997Aksys, Ltd.Method of rinsing back blood to hemodialysis patient
US5702606 *Nov 17, 1995Dec 30, 1997Aksys, Ltd.Pressure pulses cause air bubbles to be sheared off dialyzer membrane; backfiltering; removal
US5705066 *Apr 16, 1996Jan 6, 1998Aksys, Ltd.Apparatus for opening a vessel
US5707086 *Mar 14, 1996Jan 13, 1998Aksys, Ltd.Tubing connectors and parts for receiving the connectors
US5714060 *Sep 4, 1996Feb 3, 1998Aksys, Ltd.Disinfection of arterial and venous line connectors hemodialysis machine
US5716531 *Jul 15, 1997Feb 10, 1998Aksys, Ltd.Measuring electroconductivity
US5725776 *Mar 1, 1996Mar 10, 1998Aksys, Ltd.Methods for ultrafiltration control in hemodialysis
US5762782 *Jul 16, 1997Jun 9, 1998Aksys, Ltd.Water treatment for dialysate preparation
US5873853 *May 23, 1995Feb 23, 1999Baxter International Inc.Portable pump apparatus for continuous ambulatory peritoneal dialysis and a method for providing same
US5984891 *Jan 7, 1998Nov 16, 1999Baxter International Inc.Portable pump apparatus for continuous ambulatory peritoneal dialysis and a method for providing same
US6196992Nov 3, 1997Mar 6, 2001Baxter International Inc.Portable pump apparatus for continuous ambulatory peritoneal dialysis and a method for providing same
US6468241Oct 26, 2000Oct 22, 2002Chf Solutions, Inc.Disposable cartridge for filtration of blood
US6533747Oct 30, 2000Mar 18, 2003Chf Solutions, Inc.Extracorporeal circuit for peripheral vein fluid removal
US6585675Nov 2, 2000Jul 1, 2003Chf Solutions, Inc.Method and apparatus for blood withdrawal and infusion using a pressure controller
US6638478 *Feb 25, 2000Oct 28, 2003Nxstage Medical, Inc.Fluid processing procedure during which an outgoing fluid is removed from an individual and an ingoing fluid is supplied to the individual. The systems and methods supply a volume of the outgoing fluid and a volume of the ingoing fluid into a
US6649063Jul 12, 2001Nov 18, 2003Nxstage Medical, Inc.Method for performing renal replacement therapy including producing sterile replacement fluid in a renal replacement therapy unit
US6689083Nov 27, 2000Feb 10, 2004Chf Solutions, Inc.Fluid removal from overloaded patient; filter permeable to water and electrolyes but not blood protein; kidney dialysis
US6695803Oct 15, 1999Feb 24, 2004Mission Medical, Inc.Blood processing system
US6695806Oct 17, 2002Feb 24, 2004Chf Solutions, Inc.Artificial kidney set with electronic key
US6706007Dec 29, 2000Mar 16, 2004Chf Solutions, Inc.Feedback control of ultrafiltration to prevent hypotension
US6766259Jul 29, 2002Jul 20, 2004Baxter International Inc.System and a method for detecting fiber damage in a dialyzer
US6773412Apr 13, 2001Aug 10, 2004Chf Solutions, Inc.Detecting and displaying the location of a leakage, blockage, or air bubble in dialysis line
US6796955Feb 14, 2002Sep 28, 2004Chf Solutions, Inc.For use in procedures such as ultrafiltration, apheresis and dialysis; discriminates between minor occlusions that can be cured automatically or by prompting the patient to take corrective action, and more serious problems
US6817984Oct 3, 2002Nov 16, 2004Mission Medical, Inc.Blood processing system
US6871660Jun 19, 2002Mar 29, 2005Bioanalytical Systems, Inc.Pinch valve and method of operating same
US6887214Sep 12, 2000May 3, 2005Chf Solutions, Inc.Blood pump having a disposable blood passage cartridge with integrated pressure sensors
US6890315Jul 18, 2000May 10, 2005Chf Solutions, Inc.Method and apparatus for vein fluid removal in heart failure
US6923782Aug 19, 2003Aug 2, 2005Chf Solutions, Inc.User interface for blood treatment device
US7008393Oct 3, 2002Mar 7, 2006Mission Medical, Inc.Blood processing system
US7175809Mar 16, 2004Feb 13, 2007Chf Solutions Inc.Feedback control of ultrafiltration to prevent hypotension
US7214312Aug 27, 2003May 8, 2007Nxstage Medical, Inc.Fluid circuits, systems, and processes for extracorporeal blood processing
US7303540Apr 26, 2004Dec 4, 2007Chf Solutions, Inc.User interface for blood treatment device
US7311689Aug 19, 2003Dec 25, 2007Chf Solutions, Inc.Method and apparatus for peripheral vein fluid removal in heart failure
US7399289Aug 27, 2003Jul 15, 2008Chf Solutions, Inc.Controller for ultrafiltration blood circuit which prevents hypotension by monitoring osmotic pressure in blood
US7410473Apr 26, 2005Aug 12, 2008Chf Solutions Inc.Blood pump having a disposable blood filter with integrated pressure sensors
US7462161Jun 17, 2005Dec 9, 2008Chf Solutions, Inc.Method and apparatus for blood withdrawal and infusion using a pressure controller
US7534349Aug 31, 2006May 19, 2009Nephros, Inc.Dual stage ultrafilter devices in the form of portable filter devices, shower devices, and hydration packs
US7540851Jul 27, 2004Jun 2, 2009Chf Solutions, Inc.Method to control blood and filtrate flowing through an extracorporeal device
US7585286Dec 3, 2007Sep 8, 2009Chf Solutions, Inc.User interface for blood treatment device
US7615028 *Dec 3, 2004Nov 10, 2009Chf Solutions Inc.Extracorporeal blood treatment and system having reversible blood pumps
US7647834Aug 1, 2005Jan 19, 2010Chf Solutions Inc.Pressure sensor disconnect detection for a blood treatment device
US7674237Jun 24, 2003Mar 9, 2010Chf Solutions, Inc.Method and apparatus for blood withdrawal and infusion using a pressure controller
US7775375Jun 15, 2006Aug 17, 2010Medica S.R.L.Redundant ultrafiltration device
US7776001Mar 8, 2004Aug 17, 2010Nxstage Medical Inc.Registration of fluid circuit components in a blood treatment device
US7780619Jan 29, 2008Aug 24, 2010Nxstage Medical, Inc.Blood treatment apparatus
US7886611Jan 15, 2010Feb 15, 2011Chf Solutions Inc.Pressure sensor disconnect detection for a blood treatment device
US7927544Apr 21, 2006Apr 19, 2011Alung Technologies, Inc.Paracorporeal respiratory assist lung
US7935071Dec 19, 2007May 3, 2011Chf Solutions, Inc.Method and apparatus for peripheral vein fluid removal in heart failure
US7955289Dec 8, 2008Jun 7, 2011Chf Solutions, Inc.Method and apparatus for blood withdrawal and infusion using a pressure controller
US8029454Nov 4, 2004Oct 4, 2011Baxter International Inc.High convection home hemodialysis/hemofiltration and sorbent system
US8038639Sep 11, 2006Oct 18, 2011Baxter International Inc.Medical fluid system with flexible sheeting disposable unit
US8040493Oct 7, 2009Oct 18, 2011Fresenius Medical Care Holdings, Inc.Thermal flow meter
US8057423Jul 5, 2007Nov 15, 2011Baxter International Inc.Dialysis system having disposable cassette
US8105487Sep 25, 2008Jan 31, 2012Fresenius Medical Care Holdings, Inc.Manifolds for use in conducting dialysis
US8114288Nov 28, 2008Feb 14, 2012Fresenlus Medical Care Holdings, Inc.System and method for conducting hemodialysis and hemofiltration
US8137553Oct 7, 2009Mar 20, 2012Fresenius Medical Care Holdings, Inc.Priming system and method for dialysis systems
US8197432Sep 3, 2009Jun 12, 2012Gambro Uf Solutions, Inc.User interface for blood treatment device
US8240636Jan 12, 2009Aug 14, 2012Fresenius Medical Care Holdings, Inc.Valve system
US8337449Sep 26, 2011Dec 25, 2012Baxter International Inc.Dialysis system having disposable cassette
US8343347May 15, 2009Jan 1, 2013Nephros, Inc.Dual stage ultrafilter devices in the form of portable filter devices, shower devices, and hydration packs
US8395761Sep 25, 2011Mar 12, 2013Fresenius Medical Care Holdings, Inc.Thermal flow meter
US8430835Jun 4, 2010Apr 30, 2013Baxter International Inc.Renal therapy blood cleansing system with balance chamber and bolus, rinseback or prime volume feature
US8475398Nov 6, 2009Jul 2, 2013Gambro Uf Solutions, Inc.Extracorporeal blood treatment and system having reversible blood pumps
US8475399Feb 26, 2010Jul 2, 2013Fresenius Medical Care Holdings, Inc.Methods and systems for measuring and verifying additives for use in a dialysis machine
US8522832Jul 28, 2010Sep 3, 2013Icu Medical, Inc.Fluid transfer devices and methods of use
US8535521Oct 15, 2008Sep 17, 2013Baxter International Inc.Optimizing clearance for protein-bound molecules using cascade filtration therapy
US8535522Feb 12, 2010Sep 17, 2013Fresenius Medical Care Holdings, Inc.System and method for detection of disconnection in an extracorporeal blood circuit
US8597505Feb 8, 2011Dec 3, 2013Fresenius Medical Care Holdings, Inc.Portable dialysis machine
US8603021May 2, 2011Dec 10, 2013Gambro Uf Solutions, Inc.Method and apparatus for ultrafiltration of blood
US8647569Apr 11, 2011Feb 11, 2014ALung Technologies, IncParacorporeal respiratory assist lung
US8702638Aug 24, 2012Apr 22, 2014Gambro Uf Solutions, Inc.Method for blood withdrawal and infusion using a pressure controller
US8771511Jan 9, 2012Jul 8, 2014Fresenius Medical Care Holdings, Inc.Disposable apparatus and kit for conducting dialysis
USRE38869 *Sep 9, 2004Nov 8, 2005Chf Solutions Inc.Extracorporeal circuit for peripheral vein fluid removal
WO2005028002A1 *Sep 22, 2004Mar 31, 2005Dudu HaimovichBlood oxygenation system with single lumen catheter
WO2009073567A1 *Nov 28, 2008Jun 11, 2009Xcorporeal IncSystem and method for conducting hemodialysis and hemofiltration
WO2013096911A1 *Dec 21, 2012Jun 27, 2013Icu Medical, Inc.Fluid transfer devices and methods of use
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